Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions

Abstract

Background Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should be consistently reported in all clinical trials of a defined area. It comprises a core domain set (defining what core outcomes should be measured) and a core measurement set (defining measurement/assessment instruments for each core domain). For pressure ulcer prevention trials a COS is lacking. The great heterogeneity of reported outcomes in this field indicates the need for a COS. Methods/design The first part of this project aims to develop a core domain set by following established methods, which incorporates four steps: (1) definition of the scope, (2) conducting a scoping review, (3) organizing facilitated workshops with service users, (4) performing Delphi surveys and establishing consensus in a face-to-face meeting with different stakeholders. Discussion After achieving consensus on the core domain set, further work will be undertaken to determine a corresponding core measurement set. This will lead to better pressure ulcer prevention research in the future. There are a number of methodological challenges in the field of COS development. To meet these challenges and to ensure a high-quality COS, the OUTPUTS project affiliates to current standards and works in close collaboration with international experts and with existing international service user groups. Trial registration The OUTPUTs project is registered in the COMET database: ( http://www.comet-initiative.org/studies/details/283 ). Registered on 2015.

Comparing the effects of three different multilayer dressings for pressure ulcer prevention on sacral skin after prolonged loading: An exploratory crossover trial

“…Next to the "hard" clinical outcome "PU development", a number of alternative biomarkers and parameters that characterize the response of the skin to prolonged loading and deformation have been proposed to evaluate the effectiveness of PU preventive interventions. 20,21 Skin functional parameters such as erythema or stratum corneum hydration (SCH) and structural parameters, like structural stiffness, have been successfully measured in previous PU prevention research. 22,23 These parameters are able to discriminate effects of different loading intensities and skin-support surface interactions to measure PU preventive device performance.…”

Core outcomes for pressure ulcer prevention trials: results of an international consensus study

“…Developing core outcomes for prevention is a major methodological challenge. It seems to be easier to describe treatment effects changing existing diseases or health states, instead of describing intervention effects, when the health state remains stable and no signs or symptoms are expected to occur 10,33 . This challenge is also reflected in the prioritized outcomes.…”

“…Evaluations of risk of bias or quality of evidence, which are defining characteristics of systematic reviews, were not necessary. The review was conducted in 12 major databases, and both outcomes and relevant concepts in PU prevention were extracted and afterwards inductively grouped into domains 5,10 . The domains were then categorized according to the outcome domain taxonomy proposed by the COMET group 11 .…”

Prevention and treatment of pressure injuries: A meta-synthesis of Cochrane Reviews

“…Known as the Cochrane Skin Group Core Outcome Set Initiative (CSG-COUSIN), it includes the Outcomes for Pressure Ulcer Trials (OUTPUTs) group. The group recently published a protocol outlining their plan to develop core outcome sets for PI prevention so that results from PI clinical trials can be reviewed and used by researchers and clinicians [61][62][63][64][65]71], and inform researchers in planning future trials.…”